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QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Pr

Recalled December 11, 2019 · FDA recall D-0561-2020 · QuVa Pharma

Hazard
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules · FDA Class II
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Description

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
Manufacturer(s)
QuVa Pharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Pr | RecallWatchUSA